FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK AVIVA TEST STRIPS
MDR report key: 1040952
·
Received May 2, 2008
Report
- Report Number
- 1823260-2008-03711
- Event Type
- Malfunction
- Date Received
- May 2, 2008
- Date of Event
- April 28, 2008
- Report Date
- May 2, 2008
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K043474
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- LAY USER/PATIENT
Narratives
Description of Event or Problem · 1
CUSTOMER REPORTEDLY OBTAINED RESULTS OF 211MG/DL, 200MG/DL, AND 41MG/DL ON THE AVIVA SYSTEM WITHIN 10 MINUTES. NO ACTION TAKEN ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK AVIVA TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS - LFR | LFR | ROCHE DIAGNOSTICS | 301014 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | TIZANIDINE - 4MG/AS NEEDED| "SCOLACTIN" - 8 MONTHS 2400MG/DAY| NORCO - 2000 60MG/DAY| "ASIFIX" - 1 YR 20MG/DAY| LYRICA 8 MONTHS 150MG/DAY| XANAX - 1 YR 0.25MG/DAY| CELEBREX - 200MG/DAY| CMYBALTA - 2 YRS 120/DAY| NOVOLIN R 2 YRS SLIDING SCALE| NOVOLIN N 2 YRS SLIDING SCALE| AMBIEN CR - 1 YR 12.5MG/DAY |